510(k) · Cleared
ClearedUniversal Seal (5-12 mm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 14, 2026 as substantially equivalent to K253978 (Intuitive Surgical, Inc., 2026) after an 89-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jul 14, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K920110 (1992). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK920110 Endopath Disposable Thoracic Trocar SleeveETHICON, Inc. · 1992
- 6 generations backK112358 Unimax Trocar SystemUnimax Medical Systems, Inc. · 2011
- 5 generations backK133845 8MM Trocar KitIntuitive Surgical · 2014 · Recalled
- 4 generations backK181395 Universal Cannula Seal (5-12 mm)Intuitive Surgical, Inc. · 2018
- 3 generations backK231358 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2023
- 2 generations backK241360 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2024
- 1 generation backK253978 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026
- This deviceK261249 Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K920110 | Endopath Disposable Thoracic Trocar Sleeve | ETHICON, Inc. | 1992 | — |
| −6 | K112358 | Unimax Trocar System | Unimax Medical Systems, Inc. | 2011 | — |
| −5 | K133845 | 8MM Trocar Kit | Intuitive Surgical | 2014 | 2 |
| −4 | K181395 | Universal Cannula Seal (5-12 mm) | Intuitive Surgical, Inc. | 2018 | — |
| −3 | K231358 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2023 | — |
| −2 | K241360 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2024 | — |
| −1 | K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026 | — |
| 0 (this device) | K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K253978 | Universal Seal (5-12 mm)Summary page 5…uct Code: GCJ 3. Predicate Device Trade Name Universal Seal (5 – 12 mm) 510(k) Number K253978 4. Device Description The Universal Seal (5-12 mm) is a sterile, single-use device. It provides a seal within a port of entry… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 13 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The da Vinci Trocar has applications in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261249: Universal Seal (5-12 mm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261249
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026